(223 days)
Not Found
Not Found
No
The summary describes a traditional immunoassay kit for detecting Cryptosporidium oocysts using fluorescently labeled antibodies. There is no mention of AI, ML, image processing, or any computational analysis that would suggest the use of these technologies. The performance studies compare the device to other immunoassay tests.
No.
The device is intended for the detection of Cryptosporidium oocysts (diagnosis), not for treating or preventing a disease.
Yes
The device is described as a "Test" used to "detect Cryptosporidium oocysts in fecal specimens from persons suspected of having intestinal disease," which clearly indicates its purpose in diagnosing a medical condition.
No
The device description explicitly states the kit includes "ready-to-use reagents" and an "antibody reagent," indicating it is a physical kit with chemical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to detect Cryptosporidium oocysts in fecal specimens from persons suspected of having intestinal disease. This involves testing a sample taken from the body (in vitro) to diagnose a condition.
- Device Description: The description details a kit with reagents and antibodies used to perform a test on a biological sample (fecal specimens). This is characteristic of an in vitro diagnostic device.
- Anatomical Site: The anatomical site is "fecal specimens," which are samples taken from the body for analysis.
- Performance Studies: The performance studies describe comparisons with other diagnostic tests for detecting Cryptosporidium in fecal specimens. This further confirms its role as a diagnostic tool.
The definition of an In Vitro Diagnostic (IVD) device is a medical device that is used to perform tests on samples such as blood, urine, or tissue, to detect diseases or other conditions. This device fits that definition perfectly.
N/A
Intended Use / Indications for Use
The TechLab Crypto-Cel IF Test can be used to detect Cryptosporidium oocysts in fecal specimens from persons suspected of having intestinal disease due to this pathogen. The Crypto-Cel IF Test is to be used in an immunofluorescent assay. These tests serve as diagnostic aids for cryptosporidiosis by detecting the organism or its antigens.
Product codes
Not Found
Device Description
The TechLab Crypto-Cel IF Test device is a kit, which includes ready-to-use reagents, containing an antibody reagent consisting of FITC-labeled anti-Cryptosporidium monoclonal antibody. This antibody functions as the detecting antibodies. The monoclonal antibody is prepared from mouse ascites fluid.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fecal specimens
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The TechLab Crypto-Cel IF Test was compared in two studies with the Merifluor Cryptosporidium/Giardia Direct Immunofluorescent Detection Procedure (Meridian Diagnostics, Inc., Cincinnati, OH) for the detection of Cryptosporidium in fecal specimens. In addition, the TechLab test was compared with the Crypto/Giardia-Cel IF Test, for which we have submitted a 510(k) application. The results of our clinical evaluations show that the TechLab Crypto-Cel IF Test exhibits a correlation of 100% when compared with these tests.
Key Metrics
correlation of 100%
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3220
Entamoeba histolytica serological reagents.(a)
Identification. Entamoeba histolytica serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toEntamoeba histolytica in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyEntamoeba histolytica directly from clinical specimens. The identification aids in the diagnosis of amebiasis caused by the microscopic protozoan parasiteEntamoeba histolytica and provides epidemiological information on diseases caused by this parasite. The parasite may invade the skin, liver, intestines, lungs, and diaphragm, causing disease conditions such as indolent ulcers, an amebic hepatitis, amebic dysentery, and pulmonary lesions.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
0
SUMMARY OF SAFETY AND EFFECTIVENESS
- Name of Manufacturer
TechLab, Inc. Corporate Research Center 1861 Pratt Drive Blacksburg, VA 24060
AUG - 5 1996
- Establishment Registration
Federal ID # 54-1527427 Initial Registration of Medical Device Establishment, #1122855
- Trade Name
Crypto-Cel IF Test
- Common Name
Cryptosporidium Immunofluorescent Test
- Class of Device
This device is classified in Class I.
- Performance Standards
No performance standards have been developed for this device under 514 of the Food, Drug, and Cosmetic Act.
7. Safety and Effectiveness
The TechLab Crypto-Cel IF Test can be used to detect Cryptosporidium oocysts in fecal specimens from persons suspected of having intestinal disease due to this pathogen. The kit, which includes ready-to-use reagents, contains an antibody reagent consisting of FITC-labeled anti-Cryptosporidium monoclonal antibody. This antibody functions as the detecting antibodies. The monoclonal antibody is prepared from mouse ascites fluid.
1
The Crypto-Cel IF Test is to be used in an immunofluorescent assay and is substantially equivalent to an approved immunofluorescent test that can be used for the detection of Cryptosporidium and Giardia in stool specimens. These tests serve as diagnostic aids for cryptosporidiosis by detecting the organism or its antigens.
The TechLab Crypto-Cel IF Test was compared in two studies with the Merifluor Cryptosporidium/Giardia Direct Immunofluorescent Detection Procedure (Meridian Diagnostics, Inc., Cincinnati, OH) for the detection of Cryptosporidium in fecal specimens. In addition, the TechLab test was compared with the Crypto/Giardia-Cel IF Test, for which we have submitted a 510(k) application. The results of our clinical evaluations show that the TechLab Crypto-Cel IF Test exhibits a correlation of 100% when compared with these tests. These results show that the TechLab Crypto-Cel IF Test is useful for the detection of these pathogens in fecal specimens.